MAUDE Adverse Event Report: ANGIODYNAMICS 400 MICRON FIBER PROCEDURE KIT; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number EVLTPVAK

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

The fiber from a pvak -- 400 micron perforator and accessory vein ablation kit was received by the angiodynamics post market surveillance investigation team.Follow up with the account determined that the fiber was found to be fractured, at the start of treatment.There was no harm experienced by the patient.Despite multiple attempts, further details have not been provided.

Manufacturer Narrative

Returned for evaluation was a pvak evlt fiber.The returned fiber was noted to be fractured and detached.The fiber returned was plugged into the tagwrite and shows that the fiber was connected to a laser generator but it cannot be determined if it was actually fired; sample evaluation does not show indications of energy at fracture site, i.E.No melting of the buffer layer.Engineer review: the sample was returned in two pieces, with the break occurring at 16cm from distal end of gripper strain relief.The buffer had stretched/distorted, but it is uncertain when the stretching occurred as it is likely the pieces were manually separated for return of the sample.Fiber assemblies are 100% beam shape tested in final assembly stages, indicating the lowlihood of the failure occurring after that inspection.It is anticipated that the fiber material has some imperfections in the glass core which can impact the resultant fiber strength.To detect imperfections that will not withstand the minimum stress expectations, the fiber material is subjected to an in-process stress test when produced by the vendor.When packaged, the fiber assemblies are coiled to a specific diameter to ensure any stress due to the coiled configuration is not excessive and should not adversely affect the strength of the fiber assembly for its labelled shelf life the customer's reported complaint description of fiber fractured and detached was confirmed.Based on the reported complaint description the root cause for the fiber fracture is likely due to a material variability in the fiber glass core and handling of fiber device during shipping/transit/unpacking/device use a review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use which is supplied to the end user with the reported catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: 400 MICRON FIBER PROCEDURE KIT
• Type of Device: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17907088
• MDR Text Key: 325309782
• Report Number: 1319211-2023-00068
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLTPVAK5
• UDI-Public: H787EVLTPVAK5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVLTPVAK
• Device Lot Number: 5787335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 113 KG